FDA Must Act on Public Citizen Petition for Stronger Safety Warnings for Botox and Related Drugs
Nearly a dozen Botox-related suspected iatrogenic botulism cases are under investigation in Massachusetts
WASHINGTON, D.C. — On June 7, the Massachusetts Department of Public Health (DPH) alerted the public that it is investigating a cluster of recent cases of suspected iatrogenic botulism (an uncommon but serious complication caused by systemic spread of botulinum toxin that can lead to life-threatening signs and symptoms) associated with the use of cosmetic botulinum toxin (Botox) injections at a local spa.
The DPH also informed Massachusetts clinicians that “improper dosing, administration technique, or use of non-FDA-approved [Botox] products may increase the risk of systemic botulism symptoms.”
Similarly, in 2024, multistate cases with so-called “harmful reactions to counterfeit Botox” were investigated by the Centers for Disease Control and Prevention (CDC).
Azza AbuDagga, Ph.D., a health services researcher for Public Citizen’s Health Research Group, released the following statement:
“The new suspected iatrogenic botulism cases in Massachusetts highlight the urgent need for the FDA to grant our December 2023 petition. The petition asked the FDA to promptly modify the boxed warning of both therapeutic and cosmetic Botox and related botulinum drugs. The modifications are to make it clear that post-marketing cases of severe systemic iatrogenic botulism, with the use of even recommended and properly administered doses of approved formulations of these drugs, have required hospitalization and treatment with botulinum antitoxin.
“Instead of mentioning the potential risk of systemic iatrogenic botulism and related symptoms explicitly, the current labels of Botox and related botulinum drugs water down and obscure this serious risk by using a less serious term: distant spread of toxin. These labels also limit the need for administering botulinum antitoxin to the context of excessive dosing, accidental injection or oral ingestion of these products.
“Without adding the potential risks of iatrogenic botulism on the labels of all botulinum-toxin drugs, state health authorities and the CDC will have to continue to step up to do the FDA’s job: Clearly educate consumers and clinicians about this time-sensitive serious risk.”